A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)

NCT02807675 | Completed Phase 1

• 1 other identifier: CVT-301-009
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 11

Brief Summary

This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's disease (PD).

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Number of patients with Adverse Events (AEs) including Serious AEs

  up to 9 days

Secondary Outcomes (1)

• Examiner rated time to ON comparisons between treatments (CVT-301 and placebo)

  day 1 and day 3

Study Arms (2)

CVT-301, levodopa inhalation powder (LIP)

EXPERIMENTAL

designed to deliver l-dopa to the lung using the CVT-301 inhaler.

Drug: CVT-301, LIP

Placebo

PLACEBO COMPARATOR

Administered in the same way as the investigational product, except that it does not contain l-dopa.

Other: Placebo

Interventions

CVT-301, LIP DRUG

All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

CVT-301, levodopa inhalation powder (LIP)

Placebo OTHER

All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years
• diagnosis of Parkinson's disease and motor fluctuations and early morning OFF symptoms
• classified as Stage 1 to 3 on the modified Hoehn and Yahr scale for staging of PD severity (in an ON state)
• subjects who are on a l-dopa-containing therapy, not including Rytary (or equivalent), must be stable on oral l-dopa-containing therapy for at least 2 weeks prior to the Screening Visit with a l-dopa/decarboxylase inhibitor (DDI)-containing regimen
• subjects who are on a l-dopa-containing therapy, when including Rytary (or equivalent), should be on a stable dose for at least 6 weeks prior to the Screening Visit
• the frequency of l-dopa administrations must be at least 3 times during the waking day and a total daily l-dopa dose of ≤ 1600 mg.
• on a stable regimen of their standard PD medications
• on a stable regimen of any blood pressure reducing medications (if applicable) for at least 30 days prior to screening
• forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio ≥70%
• no clinically significant abnormalities that would affect ability to complete study as determined by medical history, physical examination, electrocardiogram, clinical laboratory test results
• negative drug and alcohol testing
• negative pregnancy test for all women.

You may not qualify if:

• participated in any prior study with CVT-301
• dyskinesia of a severity that would significantly interfere with the subject's ability to participate or perform study procedures (as determined by the UPDRS Part 4)
• any contraindication to performing routine spirometry or who are unable to perform a spirometry maneuver
• have a current history of symptomatic orthostatic hypotension or are treated with medications to treat orthostatic hypotension (for example droxidopa, fludrocortisone), if they have severe dysautonomia
• have chronic obstructive pulmonary disease (COPD), asthma, or another chronic respiratory disease within the last 5 years.

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (11)

Site #9015

Fountain Valley, California, 92708, United States

Location

Site #9002

Boca Raton, Florida, 33486, United States

Location

Site #9017

Hallandale, Florida, 33009, United States

Location

Site #9008

St. Petersburg, Florida, 33713, United States

Location

Site #9018

Sunrise, Florida, 33351, United States

Location

Site #9004

Tampa, Florida, 33613, United States

Location

Site #9016

Atlanta, Georgia, 30331, United States

Location

Site #9009

Chicago, Illinois, 60611, United States

Location

Site #9003

Farmington Hills, Michigan, 48334, United States

Location

Site #9005

West Bloomfield, Michigan, 48322, United States

Location

Site #9007

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

SMG1 protein, human

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Steven Komjathy, MD

  Acorda Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

US (11)